Cleared Traditional

K251971 - RPS Primary TKA Software

Also marketed or referenced as:
RPS Console RPS Saw One RPS Cable RPS Saw Oscillating Tip Cartridge RPS Console Cart Attachment Ball Tip Pointer

K251971 is the FDA 510(k) clearance for RPS Primary TKA Software by Stryker Instruments. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K251971 · Stryker Instruments · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
91d
Days
Class 2
Risk

K251971 is an FDA 510(k) clearance for the RPS Primary TKA Software. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Stryker Instruments (Portage, US). The FDA issued a Cleared decision on September 25, 2025 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Instruments devices

Submission Details

510(k) Number K251971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2025
Decision Date September 25, 2025
Days to Decision 91 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - OLO Orthopedic Stereotaxic Instrument

All 354
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K251971.
OsteoCentric Navigated Instruments System
K250520 · Osteocentric Technologies, Inc. · Oct 2025
StealthStation S8 Spine Software
K251282 · Medtronic Navigation, Inc. · Oct 2025
TMINI Miniature Robotic System
K252544 · THINK Surgical, Inc. · Oct 2025
iGPS Navigation Instruments
K251780 · SI-BONE, Inc. · Sep 2025
Spine & Trauma Navigation Instruments
K252562 · Brainlab AG · Sep 2025
Mazor X System / Mazor X Stealth Edition
K251316 · Mazor Robotics , Ltd. · Sep 2025